COVID-19 vaccine information hub

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA approving the release of the first four batches (batches 300157P, 300158P, 300160P and 300161P) totalling 832,200 doses for supply. The clearance follows last Sunday's TGA approval for the vaccine to be manufactured in Australia by CSL-Seqirus, which in turn followed its approval of the overseas-manufactured AstraZeneca vaccine last month.

TGA testing of the vaccine batches in their Canberra laboratories plus review of extensive manufacturing documentation, has ensured that the locally-manufactured vaccine has exactly the same composition and performance as the overseas-manufactured vaccine, the same quality, and is free of contaminants.

The TGA's clearance of the vaccine for local manufacture is a major step in Australia's response to the COVID-19 pandemic, ensuring secure access to large numbers of doses of a domestically-produced vaccine, with the Australian government having procured 50 million doses for delivery in the coming months.

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On Monday the roll-out of Phase 1b of the Australian Government’s vaccination plan commenced. Appointment availability will increase as the number of clinics grow from 1,000 to >4,000 over the next four weeks.

Priority groups in Phase 1b include 6.14 million Australians:

• elderly adults aged ≥80 years
• elderly adults aged ≥70 years
• health care workers not vaccinated in Phase 1a
• Aboriginal and Torres Strait Islander adults >55
• adults with a specified medical conditions
• adults with a severe disability who have a specified underlying medical condition
• critical and high-risk workers including defence, police, fire, emergency services and meat processing.

Update - European and UK reviews find no proven link with blood clots

• Safety advisory: AstraZeneca ChAdOx1-S COVID-19 vaccine

The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S vaccine in the past two days in Queensland. The TGA is conducting a comprehensive analysis of information from use of COVID-19 vaccines in Australia to date to confirm the rate of anaphylaxis observed in Australia is consistent with the expected rate.

All of the Queensland reports related to vaccine from a single batch. TGA testing of the batch prior to release confirmed that it was compliant with all requirements. The TGA has confirmed that there were no temperature deviation for the batch during importation. TGA and UK have both conducted laboratory testing of the AstraZeneca vaccine prior to release as an extra safeguard.

This testing has confirmed that the particular single batch of the AstraZeneca vaccine being used in Australia and administered at these Queensland sites is compliant with international standards, and is consistent with other batches of AstraZeneca vaccine supplied in Australia and safe to use.

Earlier this week Aljazeera reported that more than a dozen countries, mostly in Europe, have suspended the use of AstraZeneca’s COVID-19 vaccine over fears the shot may have caused some recipients to develop blood clots. Sweden and Latvia became the latest nations to halt the roll-out, following moves by Germany, Italy, France, Spain, Denmark, Norway, and The Netherlands, among others.

On Monday, the UK regulator, the Medicines and healthcare products Regulatory Agency (MHRA) released an updated response stating, 'It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so'.

The TGA has received and assessed additional data submitted by Pfizer for their COVID-19 vaccine (COMIRNATY - BNT162b2). A storage condition of ‑20±5°C for up to 2 weeks (even during transportation) within the 6-month shelf life when stored at -90 to -60°C has been approved.  An updated Product Information sheet is anticipated to be submitted by Pfizer and published on the TGA website shortly.

The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S vaccine in the past two days in Queensland. The TGA is conducting a comprehensive analysis of information from use of COVID-19 vaccines in Australia to date to confirm the rate of anaphylaxis observed in Australia is consistent with the expected rate.

All of the Queensland reports related to vaccine from a single batch. TGA testing of the batch prior to release confirmed that it was compliant with all requirements. The TGA has confirmed that there were no temperature deviation for the batch during importation. TGA and UK have both conducted laboratory testing of the AstraZeneca vaccine prior to release as an extra safeguard.

This testing has confirmed that the particular single batch of the AstraZeneca vaccine being used in Australia and administered at these Queensland sites is compliant with international standards, and is consistent with other batches of AstraZeneca vaccine supplied in Australia and safe to use.

Earlier this week Aljazeera reported that more than a dozen countries, mostly in Europe, have suspended the use of AstraZeneca’s COVID-19 vaccine over fears the shot may have caused some recipients to develop blood clots. Sweden and Latvia became the latest nations to halt the roll-out, following moves by Germany, Italy, France, Spain, Denmark, Norway, and The Netherlands, among others.

On Monday, the UK regulator, the Medicines and healthcare products Regulatory Agency (MHRA) released an updated response stating, 'It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so'.

The Australian Government Department of Health (DoH) has sought expressions of interest (EOI) from accredited general practices to take part in the planned delivery of the AstraZeneca COVID-19 vaccine from Phase 1b.

More than 4,600 practices that expressed interest in participating in the vaccine roll-out have been approved. The DoH, via Primary Health Networks, has now begun advising those approved practices.

Health Minister Greg Hunt  has announced that Australia has received another shipment of Pfizer vaccine doses, bringing the total to 443,000 in addition to the 300,000 AstraZeneca doses. This means Australia has so far received a total of 733,000 doses from overseas.

'In terms of the distribution to the states, I am very pleased to be able to announce that over the current ten-day period, we will make almost 300,000 doses available to the states and that will be the two distributions of Pfizer and one of AstraZeneca.'

Minister Hunt said the number of doses distributed to the states [and territories] would be as follows: NSW: 86,000; Vic: 76,000; Qld: ~60,000; WA: 30,000; SA: 29,000; Tas: just > 9,000; NT: 3,700; and ACT: 5,100.

'As we speak, as of last night [Monday 1 March], there had been 41,907 doses administered around the country. That included 13,348 Commonwealth aged care residents at 158 facilities.'

More than one million Australian-produced doses of the Oxford AstraZeneca vaccine are ready to be released by the end of the month. Melbourne-based company CSL is manufacturing the vaccine and said its current March timeline was well ahead of schedule.

The first Australian Government-funded training modules for the COVID-19 vaccination workforce, including for immunisation providers and non-clinical and administration staff, is now available.

The Australian Government has partnered with the Australian College of Nursing to develop and deliver the free and accredited training modules for all COVID-19 vaccination providers. The training is being provided free to all authorised COVID-19 vaccination providers.

Per Australian Government advice to SHPA, hospital pharmacists assisting immunisation professionals with supply chain logistics, storage, dose preparation and labelling, will need to access all six core modules.

To access the modules:

• Hospital pharmacists
  → select User type: As an Immunising Professional with an AHPRA number
   
• Technicians
  → select User type: As an Immunising Professional without an AHPRA number

SHPA is aware that the registration page then asks users to select which immunisation course they have undertaken, however choosing the N/A option will allow you to register with the training modules.

Other updates on the COVID-19 Vaccine program

• The Australian Government Department of Health is in the final stages of the selection process for General Practices that will take part in the COVID-19 vaccine rollout.
   
• The Australian Government has developed a stakeholder pack for multicultural audiences with information on COVID-19 vaccines.
  This pack contains in-language communication resources and key messages to inform and educate everyone in Australia about COVID-19 vaccines.
  Click on the links in the stakeholder pack to access translated COVID-19 vaccines information. Resources include audio files, videos, social media content, posters and factsheets that you can download and share with your patient community.

On 2 February 2021 during his address to the National Press Club, Prime Minister Scott Morrison announced further details of the Government’s COVID-19 Vaccine and Treatment Strategy.

Key points:

• Majority of Australians will be vaccinated with the University of Oxford/AstraZeneca COVID-19 vaccine, with CSL’s Melbourne manufacturing facility having capacity to produce enough for Australia.
• Vaccinations remain on track for distribution to priority groups (Phase 1A) by late February, despite ongoing concerns regarding vaccine export controls from Europe.
• The aim is for every Australian to have the opportunity to be vaccinated by October.
• $1.9 billion of new support for the vaccine rollout on top of $4.4 billion for vaccine purchasing adding up to a total of $6.3 billion.
• Hospitals, GPs, Pharmacies, Respiratory Clinics, Aboriginal Health Services and a specialist surge workforce are being involved in ensuring all Australians can be vaccinated.
• The TGA’s approval of the Pfizer vaccine made Australia among the few countries in the world to provide formal approval of the vaccine and not just for emergency use.
• COVID-19 vaccine rollout: Pharmacy participation in Phase 2A (from May 2021) – EOIs from community pharmacies is open.

In the first few months of the vaccination program, it is expected that there will be limited doses of the vaccine available in Australia. In Phase 1a, the priority groups will be offered the vaccines at designated vaccination hubs in the first instance. In NSW, these hubs will be located at specific sites with the required storage, vaccine handling and administration capacity. In Phase 1a, NSW Health is planning for vaccination hubs located at RPA, Westmead and Liverpool hospitals, followed by Hornsby, St George, Nepean, Newcastle, Wollongong, Coffs Harbour, Dubbo and Wagga Wagga hospitals.

As reported by The Advocate this week, North West Regional Hospital's COVID vaccination clinic began administering Pfizer vaccines on Monday, with a target of 1,170 healthcare and hotel quarantine workers in the 1a category to be vaccinated this week. A clinic will also start operating in the Launceston General Hospital (LGH).

SHPA Tas Branch Member and LGH Pharmacy Manager Liam Carter, [picutred in the article] gave Tasmania's Health Minister Sarah Courtney MP a tour of the clinic.

The 1B roll-out, which includes 180,000 Tasmanians, will begin later this week with GP and community clinics. The government expects the 1B roll-out will take four months.

• A Tasmanian Vaccination Emergency Operations Centre (TVEOC) has been activated to manage the rollout.
• EOIs for Registered Nurses interested in joining Tasmania’s COVID-19 vaccination has opened.
• The Tasmanian Government will soon be contacting pharmacists in Tasmania seeking expressions of interest from them to be involved in the vaccination rollout program*.

* This may no longer be required given national EOI has opened.

The Victorian Department of Health has made the Victorian COVID-19 vaccination guidelines (the guidelines), appendices and resources available on their website.

Currently updated weekly, the guidelines provide advice and describe the minimum requirements for delivery of the COVID-19 vaccination program in Victoria, in accordance with the requirements set out by the Commonwealth Government.

Pharmacist immunisers approved to administer vaccine in Victoria

Victoria's Department of Health has given regulatory approval for pharmacist immunisers to administer the COVID-19 vaccine in Victoria. Pharmacists in Victoria who have completed immuniser training, hold current first aid and CPR certificates – and have completed the Commonwealth COVID-19 Vaccination training, as well as any other required training – may be able to administer the vaccine. The Health Secretary also made a public health emergency order allowing registered non-immuniser pharmacists, intern pharmacists, and fourth-year pharmacy students to undertake ‘authorised vaccination activities’ in relation to the COVID-19 vaccine roll-out, for example, drawing up of the vaccine and labelling in preparation for the actual administration to a patient.

The Victorian State Government has announced that the first Victorians to receive the coronavirus vaccine will be able to do so at the following nine hubs at public hospitals in Melbourne and regional Victoria: Albury-Wodonga Health, Austin Health, Ballarat Health, Barwon Health, Bendigo Health, Goulburn Valley Health, Latrobe Health, Monash Health and Western Health. The first stage of the Pfizer-BioNTech vaccine rollout will cover quarantine and border workers, and all people working in Victoria's hotel quarantine scheme.

• SHPA is aware that the Victorian Government is in the process of establishing vaccination clinics, and is preparing for a workforce surge for the vaccination rollout. They are currently consulting health services on this, with the proposed workforce to include pharmacy technicians and final year pharmacy students.
• Again, from anecdotal info, some individual health services/hospitals are also seeking EOIs from nurses to be involved in their hospitals' COVID-19 vaccine program.